Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus Continuous Use of Fluoride Desensitizing Toothpastes in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Degree of Dentin hypersensitivity
研究概览
简要总结
The aim of the study to compare the clinical effectiveness of Episodic use of Bioactive Silica Based versus continuous use of fluoride based desensitizing toothpastes in management of dentin hypersensitivity (DH) of adult patients over 6m follow up and evaluating patient satisfaction regarding the treatment provided. Episodic use will be tested as it reflects the effectiveness in a clinical scenario regarding patient compliance and adherence to the treatment where some of the Egyptian patients stop the treatment once improvement occurs due to financial constraints
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with DH, VAS ≥ 3 and Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application.
- •Teeth with DH related to Non- carious Cervical lesions (abrasion, abfracture, erosion).
- •Teeth with gingival recession and exposed root dentin.
排除标准
- •Patients with known allergies or adverse reactions to any ingredient of the tested materials.
- •Systematic disease and/ or physical disabilities that may affect participation. • Patients who did any periodontal surgeries within the previous 3 months.
- •Patients with orthodontic appliances, or restorative work that might interfere with evaluation.
- •Patient who frequently use analgesics or any drugs that could affect the pain level.
- •Home or in-office bleaching and/ or in office fluoride application for 6 months before beginning of treatment.
- •Pregnant females with frequent vomiting attacks.
- •Systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, gastroesophageal reflux disease, GERD).
- •Excessive dietary or environmental exposure to acids.
研究组 & 干预措施
Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste,
干预措施: episodic use of the desensitizing toothpaste (Procedure)
Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste
干预措施: continuous use of the conventional desensitizing toothpaste (Procedure)
Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste
干预措施: episodic use of the desensitizing toothpaste (Procedure)
Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,
干预措施: episodic use of the desensitizing toothpaste (Procedure)
结局指标
主要结局
Degree of Dentin hypersensitivity
时间窗: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
Visual analog scale (VAS)
次要结局
- Examiner Assessment to level of patient pain(change from the baseline, 1month, 2months, 4 months, 6 months after treatment)
- Patient satisfaction with the Treatment(change from the baseline, 1month, 2months, 4 months, 6 months after treatment)
研究者
Rawda Hesham Abd ElAziz
Associate Professor, Conservative dentistry department
Cairo University